AccessGUDID - DEVICE: BFlex™ (00879123008558)

GUDID

Device Identifier (DI) Information

Brand Name: BFlex™
Version or Model: BFlex™ 2 Slim 3.8
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0570-0432
Company Name: Verathon Medical (Canada) ULC

Primary DI Number: 00879123008558
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243738320 *Terms of Use

Device Description: BFlex™ 2 Slim 3.8 Single-Use Bronchoscope

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60963	Flexible video bronchoscope, single-use	An endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOQ	Bronchoscope (Flexible Or Rigid)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193488	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0cd968d7-5147-4d11-b566-9b0038d85580
Public Version Date: April 11, 2023
Public Version Number: 1
DI Record Publish Date: April 03, 2023